by Robert Ambrogi -
Editor
BullsEye Newsletter: June 2005
Finding no medical or factual basis for an expert's opinion
that drugmaker Wyeth missed signals about the danger of a diet drug, a
Pennsylvania judge set aside a $1.36 million verdict for three plaintiffs
and ordered a new trial on the issue of Wyeth's liability.
In a ruling that offers lessons to litigators everywhere, Philadelphia Court
of Common Pleas Judge Mark I. Bernstein criticized the expert's testimony for
providing no factual basis by which the jury could evaluate his conclusions. "The
vast bulk of the purported basis of his opinion was conceded in cross-examination
to be logically irrelevant, factually incorrect or purely of circular reasoning," Bernstein
wrote in his May 10 decision in Hansen v. Wyeth.
The three plaintiffs - Lucy Hansen, Mildred Hill
and Joyce Jensen - alleged that they suffered heart valve damage
as a result of taking Pondimin, a component of the diet cocktail
fen-phen. A jury returned verdicts in their favor on Nov. 3, 2004.
Wyeth voluntarily agreed to recall Pondimin, its brand name for
fenfluramine, from the market in 1997 after the Food and Drug Administration
linked it to heart valve problems.
Judge Bernstein's opinion applied Pennsylvania evidence rule 705,
which requires that an expert, in giving an opinion or inference,
"testify as to the facts or data on which the opinion or inference
is based."
Although rule 705 has no corollary in the federal rules, The Evidence
Project at Washington College of Law has proposed amending the
federal rules to mirror the Pennsylvania rule.
"Rule 705 properly imposes a dual burden on the proponent
of opinion evidence," Judge Bernstein wrote. "First,
to present in direct examination the complete factual foundation
and basis for the opinion testimony, and secondly, to demonstrate
that this basis is independently supported by facts of record."
Opinions 'Illogical'
Plaintiffs presented a single pharmacology expert
to establish Wyeth's negligence, Dr. Harris Busch. A professor
for 38 years and a research scientist for 45 years, Dr. Busch had
been a consultant to major pharmaceutical companies and three times
earlier had consulted for the defense in fen-phen litigation. "Clearly
Dr. Busch is qualified as an expert," Judge Bernstein
concluded.
(Editor's note: IMS Expert Services had no involvement
in this case.)
Qualified though the expert was, the judge found
that on direct examination, he presented his opinion in conclusory
form, generically referring to voluminous materials as providing
the factual basis.
But on cross-examination, Judge Bernstein said, "it
was systematically demonstrated that many of the scientific bases
on which his opinion supposedly relied were illogical, inapplicable
or employed circular reasoning."
Among the faults Judge Bernstein found in Dr. Busch's testimony:
-
The plaintiffs' lawyers prescreened the material
they provided him to review and failed to give him all the
information he requested.
-
He based his opinion on the "entire record,"
without ever describing the specific facts on which he based
his opinion.
-
He testified that Wyeth's surveillance department
was not adequately staffed, but he admitted on cross-examination
that he had no factual basis for saying this.
-
His testimony that medical literature should
have signaled fenfluremine's danger was not supported by the
evidence or the literature.
-
His testimony regarding adverse drug events
was not supported by the evidence.
-
Although he testified that he had performed
an extensive literature search, he acknowledged on cross-examination
that the search was limited and that studies he referred to
failed to support his opinion.
Given these faults, Judge Bernstein said, the jury had no factual
basis on which to evaluate the expert's testimony.
"A just trial is the application of logic to a
courtroom," the judge wrote. "Where
it becomes clear that the facts on which an expert
opinion is based cannot logically support the conclusions
offered, the trial judge as gatekeeper must exclude
the testimony."
While Judge Bernstein found that Dr. Busch failed to explain
to the jury the factual basis for his opinions, he concluded
that, "if he does have a basis, the plaintiffs should
not be prohibited from proving their case." For this
reason, rather than enter judgment for Wyeth, he ordered a
new trial limited to the issue of liability.
Click
here for full text of this opinion.
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